United StatesWritten description in chemical and pharmaceutical patents
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The written description requirement in the chemical and pharmaceutical industries is based on a unique, ever-evolving factual situation applying a technologyneutral statute. Given the range of issues, drafting, prosecution and enforcement strategies have become more complicated, with the courts providing ambiguous guidance as to what is sufficient. As the Federal Circuit has warned, adequacy of written description “must be decided on its own facts” and “the precedential value of cases in this area is extremely limited” (Noelle v Lederman, 355 F3d 1343 (Fed Cir 2004)).
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